Trial record 1 of 1 for:
Thalidomide AND "Marwan Sabbagh"
Thalidomide for Patients With Mild to Moderate Alzheimer's Disease
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Banner Health.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Brian Browne, Banner Health
First received: March 25, 2010
Last updated: August 6, 2012
Last verified: August 2012
This is a 24-week, randomized, double-blind, placebo-controlled study of the effect of thalidomide and placebo on CSF (cerebral spinal fluid) and plasma biomarkers in patients with mild to moderate Alzheimer's disease. This study will evaluate the effects of 24 weeks of treatment with Thalidomide on plasma biomarkers.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||"Twenty-Four-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fixed Dose Regimens of Thalidomide and Placebo on CSF and Plasma Biomarkers in Patients With Mild to Moderate Alzheimer's Disease
Primary Outcome Measures:
- Improve cognition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
fixed dose over 8 clinic visits
Other Name: Celegene
A lumbar puncture will be done before treatment (baseline), and at 24 weeks to collect CSF for the quantification of biomarkers. As an exploratory effort, we will test the effects of thalidomide on the same biomarkers in the plasma and will determine if detectable changes mirror changes observed in the CSF.
|Ages Eligible for Study:
||50 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subjects must have a screening diagnosis of Probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
- Subjects must have a Mini-Mental State Examination (MMSE) score of 12-26
- Subject must live at home.
- Must have a caregiver to participate in this study
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094340
|Banner Sun Health Research Institute
|Sun City, Arizona, United States, 85351 |
|Contact: Marwan Sabbagh, MD 623-832-6500 firstname.lastname@example.org |
|Principal Investigator: Marwan N Sabbagh, MD |
||Carolyn Liebsack, BSN
||Banner Sun Health Research Institute
No publications provided
||Brian Browne, MARWAN SABBAGH, MD Director, Banner Health
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 25, 2010
||August 6, 2012
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Nervous System Diseases
Angiogenesis Modulating Agents
Physiological Effects of Drugs